C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma

March 5, 2019 updated by: Fabio Almeida MD, Phoenix Molecular Imaging
Positron emission tomography using carbon-11 acetate (AC-PET) may help find local or distant metastases from prostate cancer. This clinical trial is studying how this imaging test may help influence the choice and extent of initial treatments, and subsequent treatments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the role of positron emission tomography using carbon-11 acetate (AC-PET) in the initial and subsequent management of patients with prostate cancer at intermediate or high risk for recurrence after initial curative therapy.
  • Compare the value of AC-PET in predicting recurrence of prostate cancer with that of conventional approaches (e.g., pre-operative clinical staging, prostate-specific antigen, Gleason score, prostate and lymph node histology) in these patients.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85040
        • Phoenix Molecular Imaging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Male patients will be studied who have prostate cancer:

  • Diagnosed with prostate adenocarcinoma
  • Has completed conventional staging examinations, including histologic evaluation with Gleason score, CT scan of the abdomen and pelvis, and whole-body bone scintigraphy Candidate for curative prostatectomy OR curative radiotherapy OR staging lymphadenectomy prior to surgery

  • Deemed to be at intermediate or high risk for recurrence or metastatic disease after initial curative treatment, as defined by of one of the following:

    • Gleason score >= 7 or PSA >= 10
    • Gleason score < 7 or PSA <10 ng/mL with positive surgical margins, biopsy proven or suspected regional nodal involvement or conventional imaging showing limited metastatic disease that may be amenable to directed radiotherapy
    • Rising or non-responding PSA

Exclusion Criteria:

  • < 18 years old
  • claustrophobic patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PET/CT imaging with C11-Sodium Acetate
Drug: C11-Sodium Acetate
PET Imaging with C11-Sodium Acetate
Other Names:
  • C11 Acetate PET
  • Carbon 11
  • AC-PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue Biopsy of metastatic site(s)
Time Frame: Assessed within 30 days following AC-PET
Patients will undergo needle biopsy of positive metastatic findings on C11- Acetate PET/CT
Assessed within 30 days following AC-PET

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSA (prostate specific antigen)
Time Frame: Each 3 - 6 months for 24 months
PSA (prostate specific antigen) will be monitored per routine clinical follow-up
Each 3 - 6 months for 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phoenix Molecular Imaging

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

February 4, 2012

First Submitted That Met QC Criteria

February 7, 2012

First Posted (Estimate)

February 9, 2012

Study Record Updates

Last Update Posted (Actual)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMIC-AC-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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